Rotatable disk-shaped fluid sample collection device

ABSTRACT

A sample collection device for a fluid includes: a substantially disk-shaped body having a periphery; a capillary channel extending through the body and bounded by the periphery, having a first end and a second end, wherein the first end is adapted to draw the fluid into the channel by capillary action; a sample collection well located in the vicinity of the second end and in fluid communication with the capillary channel; and an axis of rotation extending through the center of the disk and which is substantially perpendicular to the major surface of the disk-shaped body. In a preferred embodiment, the sample collection device is adapted to rotate about the axis of rotation within a cartridge having a housing comprising an air vent in fluid communication with the capillary channel when the disk is rotated in a first position.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application is a divisional application of U.S. patentapplication Ser. No. 14/208,606, filed Mar. 13, 2014, which claimspriority upon U.S. Provisional Patent Application No. 61/790,961, filedMar. 15, 2013, the entire contents of each application beingincorporated herein by reference.

FIELD OF THE INVENTION

This present invention relates to a device for use in collecting andstoring fluid samples, particularly biological samples, such as whole(unseparated) blood, serum, plasma and urine taken from the human oranimal body. Such biological samples may be used in diagnostic and otherbiochemical tests. More particularly, the present invention relates tosuch a device which relies on capillary action for the collection of thefluid sample. The invention also relates to a working element comprisingthe fluid sample collection device. The present invention also relatesto the field of diagnostic assays, and in particular to lateral flowassays where an analyte to be detected is present in a biologicalsample.

BACKGROUND

Fluid samples taken from the human or animal body are required for awide variety of diagnostic and other biochemical tests, including themeasurement of immunological reactions (immunoassays). There isaccordingly a need for a device which can be conveniently used forcollecting and storing such samples. Since the samples may pose amicrobiological contamination or heath risk, the device used for theircollection should not allow unintended release of the samples duringstorage, transportation or manipulation. The sample collection device ispreferably disposable.

A known sample collection device for whole blood comprises an open-endedlinear capillary tube formed of glass. The tube typically has aninternal diameter of between one and two millimeters. To preventclotting of the collected blood, the internal surface of the tube may becoated with a suitable anticoagulant such as heparin, which may alsoserve to reduce the contact angle between the sample and the side of thetube.

In use of the known device, the skin on the tip of a patient's finger ispierced by a lancet or other sharp piercing member. The blood soelicited is drawn into the linear tube by capillary action. The volumeof the blood sample and the rate at which it is collected may bemaximized by holding the tube with a generally horizontal orientation.The volume of the sample collected in this way is usually of the order25-100 μL.

A problem associated with the blood sample collection device describedabove relates to the transportation and handling of the samplesubsequent to its collection. In particular, when the orientation of thelinear tube is changed, there is a risk that gravitational forces actingon the sample may exceed the intermolecular forces which maintain thesample in the tube, leading to the unintended release of a portion ofthe sample and the associated microbiological contamination or heathrisk. This problem may be exacerbated when the linear tube is alsosubjected to accelerations caused by sudden movements or decelerationscaused by small knocks, etc.

To prevent the unintended release of the sample, it is known to stopperone or both ends of the linear capillary tube, for example usingsilicone bungs or sealant. However, there remains a risk that a portionof the sample may be accidentally released before the ends of the tubehave been sealed or after the seal has been removed for subsequentprocessing.

Another problem with capillary tubes is the absence of an easy method toidentify the entification. This is especially important if the samplewill be moved from the site of collection.

There are many challenges in designing a sample collection device to beuse in conjuction with further sample manipulation such as diagnostictesting. These include: minimizing contamination due to prematuredispense or leakage from the sample collection device; enablingcollection directly from a patient (i.e., finger stick) as well as fromperipheral sample collection devices such as collection tubes orsyringes; insufficient transfer of the sample to the manipulationdevice; ensuring collection volume is sufficient for the samplemanipulation process; sample evaporation; minimizing the ability tore-open the sample collection device to avoid contamination; or othersources of inaccuracies in the sample manipulation process.

Thus, there is a need in the art for an improved sample collectiondevice for that overcomes the problems of the known art described above.In particular there is a need in the art for an improved samplecollection device, which fluids are generally aqueous, and particularlysuch a device for which the risk of accidentally release of a portion ofthe sample subsequent to its collection may be reduced.

SUMMARY OF THE INVENTION

The present invention is directed to an assay device that alleviates oneor more the foregoing problems described above.

One aspect of the invention is directed to a sample collection devicefor a fluid, the device comprising: a substantially disk-shaped bodyhaving a periphery; a capillary channel extending through the body andbounded by the periphery, having a first end and a second end, whereinthe first end is adapted to draw the fluid into the channel by capillaryaction; a sample collection well located in the vicinity of the secondend and in fluid communication with the capillary channel; and an axisof rotation extending through the center of the disk and which issubstantially perpendicular to the major surface of the disk-shapedbody. In a preferred embodiment, the sample collection device is adaptedto rotate about the axis of rotation within a cartridge having a housingcomprising an air vent in fluid communication with the capillary channelwhen the disk is rotated in a first position.

Another aspect of the invention is directed to a working elementcomprising: a sample collection device for a fluid, the devicecomprising: a substantially disk-shaped body having a periphery; acapillary channel extending through the body and bounded by theperiphery, having a first end and a second end, wherein the first end isadapted to draw the fluid into the channel by capillary action; and anaxis of rotation extending through the center of the disk and which issubstantially perpendicular to the major surface of the disk-shapedbody; and a cartridge having a housing comprising an air vent in fluidcommunication with the capillary channel when the disk is rotated in afirst position, and containing a sample manipulation device, wherein thesample collection device is rotatably positioned within the cartridgehousing and at least a portion of the side and top surface of the diskare exposed for application of sample. In a preferred embodiment, thesample manipulation device is an analytical chamber having an analyticalreagent thereon, such as a lateral flow assay device.

Another aspect of the invention is directed to a method for collecting asample comprising: providing a working element comprising: a samplecollection device for a fluid, the device comprising: a substantiallydisk-shaped body having a periphery; a capillary channel extendingthrough the body and bounded by the periphery, having a first end and asecond end, wherein the first end is adapted to draw the fluid into thechannel by capillary action; a sample collection well located in thevicinity of the second end and in fluid communication with the capillarychannel; and an axis of rotation extending through the center of thedisk and which is substantially perpendicular to the major surface ofthe disk-shaped body; and a cartridge having a housing comprising an airvent in fluid communication with the capillary channel when the disk isrotated in a first position, and containing a sample manipulationdevice, wherein the sample collection device is rotatably positionedwithin the cartridge and at least a portion of the side and top surfaceof the disk are exposed for application of sample; rotating the samplecollection device to a second position to position the first end intocontact with a sample, or rotating the sample collection device into athird position to position the sample collection well into contact witha sample; collecting the sample into the sample collection device;rotating the sample collection device to the first position to positionthe first end into position with sample manipulation device; andapplying air pressure to the air vent to force the sample across thebarrier and into contact with the sample manipulation device.

Another aspect of the invention is directed to a method of performing anassay on a liquid sample for the presence or concentration of one ormore analyte(s) or control(s), on the assay device described above,comprising: rotating the sample collection device to a second positionto position the first end into contact with the sample, or rotating thesample collection device into a third position to position the samplecollection well into contact with the sample; collecting the sample intothe sample collection device; rotating the sample collection device tothe first position to position the first end into position with theassay device; and applying air pressure to the air vent to force thesample into contact with a sample addition zone of the assay device;moving the sample by capillary action through a fluid flow path into areagent zone where it dissolves one or more reagents; flowing the sampleaway from the reagent zone having a dissolved reagent plume containingone or more reagents and into detection zone(s) by capillary actionthrough the fluid flow path, wherein signal(s) representative of thepresence or concentration of analyte(s) or control(s) is produced; andreading the signal(s) that are produced in the detection zones todetermine the presence or concentration of the analytes or controls.

Further objects, features and advantages of the present invention willbe apparent to those skilled in the art from detailed consideration ofthe preferred embodiments that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-C show various views of a sample collection device according toone embodiment of the invention.

FIG. 2A shows a cutaway view of a working element according to oneembodiment of the invention.

FIG. 2B shows a top planar view of a working element according to oneembodiment of the invention.

FIG. 3 shows a cutaway perspective view of a working element accordingto one embodiment of the invention.

FIGS. 4A-C show the sample collection device in the working element invarious collection and dispense positions.

FIG. 5 shows the positioning of the sample collection device in varioussample collection/aspiration and dispense positions.

FIG. 6 shows an embodiment of an assay device usable in the presentinvention.

FIG. 7 shows another embodiment of an assay device usable in the presentinvention.

FIG. 8 shows another embodiment of an assay device usable in the presentinvention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

As used in this specification and the appended claims, the singularforms “a”, “an” and “the” include plural referents unless the contextclearly dictates otherwise.

The term “about” as used in connection with a numerical value throughoutthe description and the claims denotes an interval of accuracy, familiarand acceptable to a person skilled in the art. The interval ispreferably ±10%.

The term “sample” herein means a volume of a liquid, solution orsuspension, intended to be acted upon by a sample manipulation device.Preferably, the sample is subjected to qualitative or quantitativedetermination of any of its properties, such as the presence or absenceof a component, the concentration of a component, etc. Typical samplesin the context of the present invention are human or animal bodilyfluids such as blood, plasma, serum, lymph, urine, saliva, semen,amniotic fluid, gastric fluid, phlegm, sputum, mucus, tears, stool, etc.Other types of samples are derived from human or animal tissue sampleswhere the tissue sample has been processed into a liquid, solution, orsuspension to reveal particular tissue components for examination. Theembodiments of the present invention are applicable to all bodilysamples, but preferably to samples of whole blood, urine or sputum.

In other instances, the sample can be related to food testing,environmental testing, bio-threat or bio-hazard testing, etc. This isonly a small example of samples that can be used in the presentinvention.

Non-biological samples can be aqueous or non-aqueous, for example wastewater samples for environmental testing and solutions having organicsolvents, such as alcohols for chemical processing.

One aspect of the invention is directed to a sample collection devicefor collecting a sample, such as a blood or blood-based sample, anddelivering it to a sample manipulation device that overcomes at leastsome of the disadvantages of known sample collection devices.

FIGS. 1A-1C show a preferred embodiment of the sample collection device10. The device is preferably substantially disk-shaped as shown in FIG.1A. The diameter and thickness x of the device can be any suitabledimension capable of holding a sufficient amount of sample. The term“substantially disk-shaped” as used herein means any planar shape thatis capable of rotating within the housing of a working element asdescribed below and does not necessarily have to be circular. The samplecollection device can be made from any suitable material, such as aplastics material, such as polymethyl methacrylate (other plasticmaterials can include polystyrene, polyethylene, cyclic olefins,acrylics, or moldable polyesters), and is preferably formed by moldingsuch as injection molding. Other possible materials include glass,metal, ceramic, etc. In a preferred embodiment, the device is at leastpartially transparent for the flow of the fluid in the capillary channelcan be observed.

Positioned within and bounded by the periphery of the disk-shaped bodyis a capillary channel 11 having dimensions sufficient to hold a desiredamount of sample. The capillary channel may have any cross-sectionalshape, for example circular or substantially semi-circular (“U” shaped)cross-sections. A substantially semi-circular cross-sectional shape isparticularly convenient if the passage is to be defined between two flatcomponents in contact with each other, since only one of the componentsthen needs to be grooved. FIGS. 1A and 1B show a particularly preferredembodiment, where the disk is made of two flat pieces that are joinedtogether to form the capillary channel. FIG. 1A shows the device withboth of the pieces joined. In this embodiment, the top piece 15A isjoined to the bottom piece 15B, such as by an adhesive. The top piece ispreferably a hydrophilic tape. FIG. 15B shows only the bottom piece 15Bwith the U-shaped channel. The dimensions of the channel are selectedsuch that capillary flow of the fluid being sampled will be achieved.For a biological sample, such as blood or plasma, the channel willpreferably have a cross-section that is in the range of 0.25-3.0 mm²,preferably 0.5-3.0 mm². The volume of the capillary channel may be inthe range 10 μL to 100 μL, preferably in the range 10 μL to 70 μLm andmore preferably 20 μL to 50 μL. The length of the capillary channel ispreferably 20 mm-100 mm. For aqueous samples, the capillary channel ispreferably treated to render the surface hydrophilic, if it is notalready. In addition, for biological samples, such as whole blood, otheradditives can be included to preserve the biological sample, such asanti-coagulants such as heparin, sodium citrate, or EDTA.

The capillary channel has a first end and a second end. The first end 12of the channel is adapted to draw fluid into the capillary channel.Preferably, the first end opens on the side surface of the disk-shapedbody in order to simplify sample collection from a live subject asdescribe in more detail below. However, in some embodiments, it may bepreferable to have the first end opening onto the top or bottom surfaceof the disk-shaped collection device.

Located in fluid communication with the second end 13 is a samplecollection well 14. The sample collection well 14 preferably opens ontothe top surface of the disk and can simply be a concavity in the top ofthe disk. The collection well is preferably hydrophilic to assist inacquiring and retaining the sample. Various hydrophilic coatings andmaterials can be used to render the well hydrophilic, including the samematerials described with respect to the capillary channel. In apreferred embodiment, the sample collection well will align with a portor vent in the cartridge, which is connected to a source of air pressureto pressurize the capillary channel as described in more detail below.In a preferred embodiment, the well is be sized to hold approximatelythe same volume as the channel, so as to prevent possible sampleoverload.

The shape of the capillary channel can be straight or more preferably atleast partially non-linear. By having at least a non-linear portion themaximum gravitational forces which can act on the collected sample (withthe device in any orientation) are reduced, as compared to a sample in aconventional linear capillary tube of comparable type. In a preferredembodiment, the capillary channel has a semi-circular shape, such as theshape of a shepherd's staff as shown in FIG. 1C, with a straight portion11 a extending radially inward from the first end 12 and forming asemi-circular portion 11 b that ends at the second end 13.

The sample collection device is preferably part of a working element 20for performing some aspect of sample manipulation, such as a diagnosticassay, described in more detail below. Other sample manipulation couldinclude microfluidics devices that can be used to obtain a variety ofinteresting measurements including molecular diffusion coefficients,fluid viscosity, pH, chemical binding coefficients and enzyme reactionkinetics. Other applications for microfluidic devices include capillaryelectrophoresis, isoelectric focusing, flow cytometry, sample injectionof proteins for analysis via mass spectrometry, PCR amplification, DNAanalysis, cell manipulation, cell separation, cell patterning andchemical gradient formation.

The working element 20 includes a cartridge 30 for housing variouscomponents of the working element. FIG. 2A is a top cut away view of theworking element 20 and its components. The sample collection device 10is located at a first end 21 of the working element as shown in thelower portion of FIG. 2A and in more detail in FIG. 3. The samplecollection device is preferably fully contained within the cartridge 30,except for a small recess 31 in the cartridge housing which forms acorresponding notch in the cartridge to expose a portion of the samplecollection device 10. In FIG. 2B, the sample collection device ispositioned within the cartridge such that the first end 12 is exposed inthe recess 31. In FIGS. 2A and 3, neither the first or second end of thesample collection device is exposed in recess 31. Alternatively, thesample collection device 10 can be held within the cartridge housingsuch that a portion of the device 10 protrudes from the end 21 of theworking element without any recess.

The cartridge housing is preferably formed of two molded halves that canbe snap fit together or welded together. Alternatively, the cartridgehousing can include molded top cover and a laminated film.

Other features of the cartridge housing include an air vent or port 32for application of air pressure to the capillary channel. As describedabove, the vent 32 aligns with the sample collection well 14 when thesample collection device is rotated to a dispense position (describedbelow), to provide fluid communication between the capillary channel anda source of compressed air (not shown).

The cartridge housing can also include an opening 33 that roughlycorresponds to the shape of the capillary channel to allow visual orother observation of the sample in the channel. In addition, an opening34 can be provided that provides access to the sample manipulationdevice 40 of the working element. For example, if the samplemanipulation device is a lateral flow diagnostic assay the opening 34can be used to apply a wash fluid to the assay.

The sample collection device 10 is rotatably held within the cartridgehousing 30, whereby it can rotate between various aspirate and dispensepositions. In a preferred embodiment, the sample collection device canhave pins extending above and below from the center. The pins arerotatably held by corresponding features in both halves of thecartridge, such as slots (not shown). Alternatively, the collectiondevice can have slot or hole in the center through which a pin or rodfrom the cartridge extends therethrough.

The working element also includes a sample manipulation device 40 forconducting further analysis or processing of a sample. Such processingor analysis can include the microfluidics applications described above.As noted above, a particularly preferred sample manipulation is alateral flow diagnostic assay described in more detail below withreference to FIGS. 6-8. The sample manipulation device 40 may include apre-manipulation portion 41, such as a filter for filtering whole blood.After application of the sample to the sample manipulation device 40,the working element can be further used in devices, such as an analyzerfor detecting and analyzing a single, or a chemical processor forfurther processing of the sample, or any other type of microfluidicsdevices described above. A particularly preferred analyzer is afluorometer.

The sample manipulation device 40 and optionally the pre-manipulationportion 41 are in fluid communication with the first end 12 when thesample collection device 10 is in a first or dispense position asdescribed below.

As noted above, the sample collection device is rotatable within thecartridge housing. This allows the device to move from multiple samplecollection or aspiration positions to position(s) where the sample canbe dispensed to the sample manipulation device or pre-manipulationportion. FIGS. 4A and 4B show the sample collection device in twopossible sample collection or aspiration positions. The FIG. 4A positionor the second position shows the first end 12 of the capillary channel11 exposed to the outside environment through the recess 31, while thesecond end 13 is within the cartridge housing. In the second positionthe first end 12 can be directly contacted with the sample to becollected, such as a drop of blood from a finger stick. By capillaryforces, the sample will be drawn or aspirated into the capillarychannel. The progression of the sample into the channel can be observedby the opening 33.

When a desired amount of sample has been collected, the samplecollection device can then be rotated to the first or dispense positionas shown in FIG. 4C. In a preferred embodiment, the rotation isapproximately 180 degrees. In the first position, the first end 12 ofthe capillary channel is rotated to position it with the samplemanipulation device 40 or pre-manipulation portion 41. Due to thepreferred shepherd's staff design when the first end 12 is positioned atthe sample manipulation device 40 or pre-manipulation portion 41, thesecond end 13 is in fluid communication with air vent or port 32. Ofcourse, if another shape for the capillary channel is selected the airvent or port would be positioned such that it would line-up or be influid communication with the second end 13. A source of compressed air(not shown) is then applied and the sample is forced to move from thecapillary channel through the first end 12 and into the samplemanipulation device 40 or pre-manipulation 41 portion of the workingelement. The compressed air may be supplied by any suitable means, suchas by a rubber diaphragm that may or may not be part of an instrument orprocessing apparatus that further handles the working element.

Instead of rotating the first end 12 directly to the first or sampledispense position, it is possible to instead rotate the first end 12 toan intermediate position, such that it is neither exposed to theenvironment through the recess 31 or in fluid communication with thesample manipulation device 40 or pre-manipulation portion 41. The firstand second ends of the capillary channel are contained within thecartridge housing and preferably would be in contact with a sealingmaterial positioned within cartridge housing, such as a piece ofelastomer, that effectively temporarily seals or plugs the capillarychannel until the sample is ready for use. This would prevent prematuretransfer of sample to the sample manipulation device, such as by gravityduring handling.

The FIG. 4B position or the third position shows the second end 13 ofthe capillary channel 11 exposed to the outside environment through therecess 31, while the first end 12 is within the cartridge housing. Inthe third position the second end 13 having the sample collection well14 can have sample applied to it such as by a syringe filling the samplecollection well 14. By capillary forces, the sample will be drawn fromthe sample well into the capillary channel. The progression of thesample into the channel can be observed by the opening 33.

When a desired amount of sample has been collected, the samplecollection device can then be rotated to the first or dispense positionas shown in FIG. 4C and the sample dispensed in the manner describedabove. In a preferred embodiment, the rotation is approximately 90degrees.

As also described above, instead of rotating the first end 12 directlyto the first or sample dispense position, it is possible to insteadrotate the first end 12 to an intermediate position, such that it isneither exposed to the environment through the recess 31 or in fluidcommunication with the sample manipulation device 40 or pre-manipulationportion 41. The first and second ends of the capillary channel arecontained within the cartridge housing and preferably would be incontact with a sealing material positioned within cartridge housing,such as a piece of elastomer, that effectively temporarily seals orplugs the capillary channel until the sample is ready for use. Thiswould prevent premature transfer of sample to the sample manipulationdevice, such as by gravity during handling.

The top row of FIG. 5 shows another view of sample collection oraspiration with the first end of the capillary channel followed byrotation from the second position to the first or dispense position,where air pressure is applied at the second end of the capillary channelto move the sample from the capillary channel to the sample manipulationor pre-manipulation portion, in this case, a whole blood filter.

Likewise, the bottom row of FIG. 5 shows another view of samplecollection with the second end of the capillary channel followed byrotation from the third position to the first or dispense position,where air pressure is applied at the second end of the capillary channelto move the sample from the capillary channel to the sample manipulationor pre-manipulation portion, in this case, a whole blood filter.

In a preferred embodiment, the sample manipulation part of the cartridgeor a cassette is a diagnostic assay. Diagnostic assays are widespreadand central for the diagnosis, treatment and management of manydiseases. Different types of diagnostic assays have been developed overthe years in order to simplify the detection of various analytes inclinical samples such as blood, serum, plasma, urine, saliva, tissuebiopsies, stool, sputum, skin or throat swabs and tissue samples orprocessed tissue samples. These assays are frequently expected to give afast and reliable result, while being easy to use and inexpensive tomanufacture.

Examples of diagnostic assays include, but are not limited to, thedetermination of analytes, also called markers, specific for differentdisorders, e.g. chronic metabolic disorders, such as blood glucose,blood ketones, urine glucose (diabetes), blood cholesterol(atherosclerosis, obesity, etc); markers of other specific diseases,e.g. acute diseases, such as coronary infarct markers (e.g. troponin-T,NT-ProBNP), markers of thyroid function (e.g. determination of thyroidstimulating hormone (TSH)), markers of viral infections (the use oflateral flow immunoassays for the detection of specific viralantibodies); etc.

Yet another important field is the field of companion diagnostics wherea therapeutic agent, such as a drug, is administered to an individual inneed of such a drug. An appropriate assay is then conducted to determinethe level of an appropriate marker to determine whether the drug ishaving its desired effect. Alternatively, the assay device of thepresent invention can be used prior to administration of a therapeuticagent to determine if the agent will help the individual in need.

Yet another important field is that of drug tests, for easy and rapiddetection of drugs and drug metabolites indicating drug abuse; such asthe determination of specific drugs and drug metabolites (e.g. THC) inurine samples etc.

The term “analyte” is used as a synonym of the term “marker” andintended to encompass any chemical or biological substance that ismeasured quantitatively or qualitatively and can include smallmolecules, proteins, antibodies, DNA, RNA, nucleic acids, viruscomponents or intact viruses, bacteria components or intact bacteria,cellular components or intact cells and complexes and derivativesthereof.

The term “reaction” is used to define any reaction, which takes placebetween components of a sample and at least one reagent or reagents onor in the substrate, or between two or more components present in thesample. The term “reaction” is in particular used to define thereaction, taking place between an analyte and a reagent as part of thequalitative or quantitative determination of the analyte.

The term “substrate” means the carrier or matrix to which a sample isadded, and on or in which the determination is performed, or where thereaction between analyte and reagent takes place.

A common type of disposable assay device includes a zone or area forreceiving the liquid sample, a conjugate zone also known as a reagentzone, and a reaction zone also known as a detection zone. These assaydevices are commonly known as lateral flow test strips. They employ aporous material, e.g., nitrocellulose, defining a path for fluid flowcapable of supporting capillary flow. Examples include those shown inU.S. Pat. Nos. 5,559,041, 5,714,389, 5,120,643, and 6,228,660 all ofwhich are incorporated herein by reference in their entireties.

The sample-addition zone frequently consists of a more porous material,capable of absorbing the sample, and, when separation of blood cells isdesired, also effective to trap the red blood cells. Examples of suchmaterials are fibrous materials, such as paper, fleece, gel or tissue,comprising e.g. cellulose, wool, glass fiber, asbestos, syntheticfibers, polymers, or mixtures of the same.

Another type of assay device is a non-porous assay having projections toinduce capillary flow. Examples of such assay devices include the openlateral flow device as disclosed in WO 2003/103835, WO 2005/089082, WO2005/118139, and WO 2006/137785, all of which are incorporated herein byreference in their entireties.

A non-porous assay device is shown in FIG. 6. The assay device 1, has atleast one sample addition zone 2, a reagent zone 3, at least onedetection zone 4, and at least one wicking zone 5. The zones form a flowpath by which sample flows from the sample addition zone to the wickingzone. Also included are capture elements, such as antibodies, in thedetection zone 4, capable of binding to the analyte, optionallydeposited on the device (such as by coating); and a labeled conjugatematerial also capable of participating in reactions that will enabledetermination of the concentration of the analyte, deposited on thedevice in the reagent zone, wherein the labeled conjugate materialcarries a label for detection in the detection zone. The conjugatematerial is dissolved as the sample flows through the reagent zoneforming a conjugate plume of dissolved labeled conjugate material andsample that flows downstream to the detection zone. As the conjugateplume flows into the detection zone, the conjugated material will becaptured by the capture elements such as via a complex of conjugatedmaterial and analyte (as in a “sandwich” assay) or directly (as in a“competitive” assay. Unbound dissolved conjugate material will be sweptpast the detection zone into the at least one wicking zone 5.

An instrument such as that disclosed in US 20060289787A1,US20070231883A1, U.S. Pat. No. 7,416,700 and U.S. Pat. No. 6,139,800 allincorporated by reference in their entireties is able to detect thebound conjugated analyte and label in the reaction zone. Common labelsinclude fluorescent dyes that can be detected by instruments whichexcite the fluorescent dyes and incorporate a detector capable ofdetecting the fluorescent dyes. Such instruments have a read window thathas a width that is typically on the order of 1 mm, which is a generallysufficient width to read enough signal, subject to an adequate width ofthe conjugate plume.

FIG. 7 shows a schematic view of a preferred lateral flow assay deviceusable as the sample manipulation device 40. The assay device 100 has atleast one sample zone (also referred to as sample addition zone) 200, atleast one reagent zone 300, at least one detection zone 400, and atleast one wicking zone 500. The zones form a flow path by which sampleflows from the sample addition zone to the wicking zone.

Components of the assay device and any other part of the working element(i.e., a physical structure of the device whether or not a discretepiece from other parts of the device) can be prepared from copolymers,blends, laminates, metalized foils, metalized films or metals.Alternatively, device components can be prepared from copolymers,blends, laminates, metalized foils, metalized films or metals depositedone of the following materials: polyolefins, polyesters, styrenecontaining polymers, polycarbonate, acrylic polymers, chlorinecontaining polymers, acetal homopolymers and copolymers, cellulosics andtheir esters, cellulose nitrate, fluorine containing polymers,polyamides, polyimides, polymethylmethacrylates, sulfur containingpolymers, polyurethanes, silicon containing polymers, glass, and ceramicmaterials. Alternatively, components of the device are made with aplastic, elastomer, latex, silicon chip, or metal; the elastomer cancomprise polyethylene, polypropylene, polystyrene, polyacrylates,silicon elastomers, or latex. Alternatively, components of the devicecan be prepared from latex, polystyrene latex or hydrophobic polymers;the hydrophobic polymer can comprise polypropylene, polyethylene, orpolyester. Alternatively, components of the device can comprise TEFLON®,polystyrene, polyacrylate, or polycarbonate. Alternatively, devicecomponents are made from plastics which are capable of being embossed,milled or injection molded or from surfaces of copper, silver and goldfilms upon which may be adsorbed various long chain alkanethiols. Thestructures of plastic which are capable of being milled or injectionmolded can comprise a polystyrene, a polycarbonate, or a polyacrylate.In a particularly preferred embodiment, the assay device is injectionmolded from a cyclo olefin polymer, such as those sold under the nameZeonor®. Preferred injection molding techniques are described in U.S.Pat. Nos. 6,372,542, 6,733,682, 6,811,736, 6,884,370, and 6,733,682, allof which are incorporated herein by reference in their entireties.

The flow path can include open or closed paths, grooves, andcapillaries. Preferably the flow path comprises a lateral flow path ofadjacent projections, having a size, shape and mutual spacing such thatcapillary flow is sustained through the flow path. In one embodiment,the flow path is in a channel within the substrate having a bottomsurface and side walls. In this embodiment, the projections protrudefrom the bottom surface of the channel. The side walls may or may notcontribute to the capillary action of the liquid. If the sidewalls donot contribute to the capillary action of the liquid, then a gap can beprovided between the outermost projections and the sidewalls to keep theliquid contained in the flow path defined by the projections. FIG. 6shows projections 7.

In one embodiment the flow path is at least partially open. In anotherembodiment the flow path is entirely open. Open means that there is nolid or cover at a capillary distance. Thus the cover, if present as aphysical protection for the flow path, does not contribute to thecapillary flow in the flow path. An open lateral flow path is describedfor example in the following published applications: WO 2003/103835, WO2005/089082; WO 2005/118139; WO 2006/137785; and WO 2007/149042, all ofwhich are incorporated by reference in their entireties. The projectionshave a height (H), diameter (D) and a distance or distances between theprojections (t1, t2) such, that lateral capillary flow of the fluid,such as plasma, preferably human plasma, in the zone is achieved. Thesedimensions are shown in US 2006/0285996, which is incorporated byreference in its entirety. In addition to optimizing the above-mentionedheight, diameter and a distance or distances between the projections,the projections may be given a desired chemical, biological or physicalfunctionality, e.g. by modifying the surface of the projections. In oneembodiment, the projections have a height in the interval of about 15 toabout 150 μm, preferably about 30 to about 100 μm, a diameter of about10 to about 160 μm, preferably 40 to about 100 μm, and a gap or gapsbetween the projections of about 3 to about 200 μm, preferably 5 toabout 50 μm or 10 to 50 μm from each other. The flow channel may have alength of about 5 to about 500 mm, preferably about 10 to about 100 mm,and a width of about 0.3 to about 10 mm, preferably about 0.3 to about 3mm, preferably about 0.5 to 1.5, and preferably about 0.5 to 1.2 mm.

While most detection will occur in the detection zone portion of thefluid flow path, it is also possible that detection may occur in otherparts of the device. For example, non-invasive, non-reactive sampleintegrity measurements may occur between the sample zone and the reagentzone or reagent addition zone, preferably after a filter element, ifpresent. Other measurements may include blanks reads, one part of a twopart reaction sequence as for measuring both hemoglobin and glycatedhemoglobin for determination of HbA1c, etc.

The liquid sample zone 200, also referred to as the liquid sampleaddition zone, receives sample from the sample collection device 10. Thesample addition zone is capable of transporting the liquid sample fromthe point where the sample is deposited to the reagent zone, through anoptional filter and reagent addition zone, preferably through capillaryflow. The capillary flow inducing structure can include porousmaterials, such as nitrocellulose, or preferably through projections,such as micro-pillars, as shown in FIG. 6. In those devices that can usefinger stick volumes of blood, the sample can be directly touched offfrom the finger, or by a capillary pipette.

Located between the sample addition zone and the detection zone is areagent zone 300. The reagent zone can include reagent material(s)integrated into the analytical element and are generally reagents usefulin the reaction—binding partners such as antibodies or antigens forimmunoassays, substrates for enzyme assays, probes for moleculardiagnostic assays, or are auxiliary materials such as materials thatstabilize the integrated reagents, materials that suppress interferingreactions, etc. Generally one of the reagents useful in the reactionbears a detectable signal as discussed below. In some cases the reagentsmay react with the analyte directly or through a cascade of reactions toform a detectable signal such as, but not restricted to, a moleculedetectable using spectroscopy such as a colored or fluorescent molecule.In one preferred embodiment, the reagent zone includes conjugatematerial. The term conjugate means any moiety bearing both a detectionelement and a binding partner.

The detection element is an agent which is detectable with respect toits physical distribution or/and the intensity of the signal itdelivers, such as but not limited to luminescent molecules (e.g.fluorescent agents, phosphorescent agents, chemiluminescent agents,bioluminescent agents and the like), colored molecules, moleculesproducing colors upon reaction, enzymes, radioisotopes, ligandsexhibiting specific binding and the like. The detection element alsoreferred to as a label is preferably chosen from chromophores,fluorophores, radioactive labels, and enzymes. Suitable labels areavailable from commercial suppliers, providing a wide range of dyes forthe labeling of antibodies, proteins, and nucleic acids. There are, forexample, fluorophores spanning practically the entire visible andinfrared spectrum. Suitable fluorescent or phosphorescent labels includefor instance, but are not limited to, fluoresceins, Cy3, Cy5 and thelike. Suitable chemoluminescent labels are for instance but are notlimited to luminol, cyalume and the like.

Similarly, radioactive labels are commercially available, or detectionelements can be synthesized so that they incorporate a radioactivelabel. Suitable radioactive labels are for instance but are not limitedto radioactive iodine and phosphorus; e.g. ¹²⁵I and ³²P.

Suitable enzymatic labels are, for instance, but are not limited to,horseradish peroxidase, beta-galactosidase, luciferase, alkalinephosphatase and the like. Two labels are “distinguishable” when they canbe individually detected and preferably quantified simultaneously,without significantly disturbing, interfering or quenching each other.Two or more labels may be used, for example, when multiple analytes ormarkers are being detected.

The binding partner is a material that can form a complex that can beused to determine the presence of or amount of an analyte. For example,in an “sandwich” assay, the binding partner in the conjugate can form acomplex including the analyte and the conjugate and that complex canfurther bind to another binding partner, also called a capture element,integrated into the detection zone. In a competitive immunoassay, theanalyte will interfere with binding of the binding partner in theconjugate to another binding partner, also called a capture element,integrated into the detection zone. Example binding partners included inconjugates include antibodies, antigens, analyte or analyte-mimics,protein, etc.

Optionally located in the fluid flow path, before or after the reagentzone and before the detection zone is a reagent addition zone. Thereagent addition zone is shown as 350 in FIG. 8. The reagent additionzone can allow addition of a reagent externally from the device. Forexample, the reagent addition zone may be used to add an interruptingreagent that may be used to wash the sample and other unbound componentspresent in the fluid flow path into the wicking zone. In a preferredembodiment the reagent addition zone 350 is located after the reagentzone 300.

Downstream from the liquid sample zone and the reagent zone is thedetection zone 400 which is in fluid communication with the sampleaddition zone. The detection zone 400 may include projections such asthose described above. As also noted above, these projections arepreferably integrally molded into the substrate from an optical plasticmaterial such as Zeonor, such as injection molding or embossing. Thewidth of the flow channel in the detection zone is typically on theorder of 2 mm for conventional size devices, however, some lower volumedevices, such as those described above and in co pending applicationentitled “Lower Volume Assay Device Having Increased Sensitivity,” Ser.No. 13/744,617, filed on Jan. 20, 2013 and incorporated by reference inits entirety, are significantly narrower, e.g., 1.5 mm or less,preferably 0.5 to 1.2 mm.

The detection zone is where any detectable signal is read. In apreferred embodiment attached to the projections in the detection zoneare capture elements. The capture elements can include binding partnersfor the conjugate or complexes containing the conjugate, as describedabove. For example, if the analyte is a specific protein, the conjugatemay be an antibody that will specifically bind that protein coupled to adetection element such as a fluorescence probe. The capture elementcould then be another antibody that also specifically binds to thatprotein. In another example, if the marker or analyte is DNA, thecapture molecule can be, but is not limited to, syntheticoligonucleotides, analogues thereof, or specific antibodies. Othersuitable capture elements include antibodies, antibody fragments,aptamers, and nucleic acid sequences, specific for the analyte to bedetected. A non-limiting example of a suitable capture element is amolecule that bears avidin functionality that would bind to a conjugatecontaining a biotin functionality. The detection zone can includemultiple detection zones. The multiple detection zones can be used forassays that include one or more markers. In the event of multipledetection zones, the capture elements can include multiple captureelements, such as first and second capture elements. The conjugate canbe pre-deposited on the assay device, such as by coating in the reagentzone. Similarly the capture elements can be pre-deposited on the assaydevice on the detection zone. Preferably, both the detection and captureelements are pre-deposited on the assay device, on the detection zoneand detection zone, respectively.

After the sample has been delivered to the sample zone, it willencounter the reagent zone. After the sample has flowed through andinteracted with the reagent zone and optionally the reagent additionzone, the sample and a reagent plume will be contained in the fluidflow. The reagent plume can contain any of the reagent materials thathave been dissolved in the detection zone or those added through thereagent addition zone. The reagent in the sample flowing from thereagent zone, but before the reagent addition zone is considered to be areagent plume. The reagent plume can include the conjugate having boththe detection element and binding partner, in which case it is oftenreferred to as a conjugate plume.

Downstream from the detection zone is a wicking zone in fluidcommunication with the detection zone. The wicking zone is an area ofthe assay device with the capacity of receiving liquid sample and anyother material in the flow path, e.g., unbound reagents, wash fluids,etc. The wicking zone provides a capillary force to continue moving theliquid sample through and out of the detection zone. The wicking zonecan include a porous material such as nitrocellulose or can be anon-porous structure such as the projections described herein. Thewicking zone can also include non-capillary fluid driving means, such asusing evaporative heating or a pump. Further details of wicking zones asused in assay devices according to the present invention can be found inpatent publications US 2005/0042766 and US 2006/0239859, both of whichare incorporated herein by reference in their entireties. Wicking zonesare also described in copending patent application entitled “ControllingFluid Flow Through An Assay Device,” Ser. No. 13/744,641, filed on Jan.18, 2013, and incorporated by reference in its entirety.

Preferably the entirety of the flow path including the sample additionzone, the detection zone and the wicking zone includes projectionssubstantially vertical in relation to the substrate, and having aheight, diameter and reciprocal spacing capable of creating lateral flowof the sample in the flow path.

In any of the above embodiments, the device is preferably a disposableassay device. The assay device may be contained in a housing for ease ofhandling and protection. If the assay device is contained in such ahousing, the housing will preferably include a port for adding sample tothe assay device.

The assay device of the present invention can be used with a device forreading (a reader) the result of an assay device performed on the assayof the present invention. The reader includes means for reading a signalemitted by, or reflected from the detection element, such as aphotodetector, and means for computing the signal and displaying aresult, such as microprocessor that may be included within an integratedreader or on a separate computer. Suitable readers are described forexample in US 2007/0231883 and U.S. Pat. No. 7,416,700, both of whichare incorporated by reference in their entireties.

Another embodiment is a device for reading the result of an assayperformed on an assay device, wherein the device comprises a detectorcapable of reading a signal emitted from or reflected from at least onedetection element present in a defined location of the assay device. Ineither of the above embodiments, the reading preferably is chosen fromthe detection and/or quantification of color, fluorescence,radioactivity or enzymatic activity.

The assay device along with the rest of the cartridge can be used toperform an assay on a liquid sample for the detection of one or moreanalytes of interest. A liquid sample containing the analyte(s) ofinterest is collected using the sample collection device as describedabove and is then dispensed onto the sample zone of the assay device.The sample moves by capillary action through an optional filter and intothe reagent zone where it encounters the multiple reagent materials. Thesample flows past the first, second and third reagent material. Thereagent material flowing past the second and third reagent materialsform second and third reagent plumes along the edges of the reagentcell. The sample flowing past the first reagent material forms a firstreagent plume long the line of symmetry of the reagent cell. The first,second and third reagent material combine upon leaving the reagent cellto form a combined reagent plume.

Next the sample and reagent plume move by capillary action into thedetection zone. There a signal representative of the presence orconcentration of the analyte(s) or control is produced. In a preferredembodiment the sample or the one or more reagents having a detectionelement is captured having in the detection zone, such as by antibodieson the surface of the detection zone and a signal representative of thepresence or concentration of the analyte(s) or control(s) is produced.

The reader as described above is then used to read the signal that isproduced by the detection element to determine the presence orconcentration of the analyte(s). The sample moves from the detectionzone and into the wicking zone. The reader may read the signalimmediately or a short time after the sample has moved through thedetection zone. Also, one or more washes may follow the sample throughthe device to wash any unbound detection element away from the detectionzone. The cartridge 20 containing the lateral flow assay device can beinserted into the reader either before or after the sample has beendispensed to the sample collection zone. In those embodiments where asource of compressed air is used to dispense the sample, the cartridgecan first be inserted into the reader and the compressed air can then beused to force sample from the sample collection device to the assaydevice.

The method, assay device, and reader according to an embodiment of theinvention have many advantages, mainly related to the improved detectionkinetics of the immunochemical reactions and the increased sensitivityof the assay. It is to be understood that this invention is not limitedto the particular embodiments shown here.

Additional Embodiments

1. A sample collection device for a fluid sample, the device comprising:a substantially disk-shaped body having a periphery; a capillary channelextending through the body and bounded by the periphery, having a firstend and a second end, wherein the first end is adapted to draw the fluidinto the channel by capillary action;

a sample collection well located in the vicinity of the second end andin fluid communication with the capillary channel; and an axis ofrotation extending through the center of the disk and which issubstantially perpendicular to the major surface of the disk-shapedbody.

2. A sample collection device as disclosed in embodiment 1, wherein thesample collection device is adapted to rotate about the axis of rotationwithin a cartridge having a housing comprising an air vent in fluidcommunication with the capillary channel when the disk is rotated in afirst position.

3. A sample collection device as disclosed in embodiment 2, wherein theair vent is located in the vicinity of and in fluid communication withthe second end of the capillary channel when the disk is rotated in afirst position.

4. A sample collection device as disclosed in embodiment 1, wherein theopening of the first end is located on the side surface of the disk andthe well is located on the top surface of the disk.

5. A sample collection device as disclosed in embodiment 1, wherein thecapillary channel is non-linear.

6. A sample collection device as disclosed in embodiment 5, wherein thecapillary channel has a semi-circular shape.

7. A sample collection device as disclosed in embodiment 6, wherein thecapillary channel has a staff shape.

8. A sample collection device as disclosed in embodiment 1, wherein thefirst end is hydrophilic.

9. A sample collection device as disclosed in embodiment 8, wherein thefirst end is provided with a hydrophilic coating.

10. A working element comprising: a sample collection device for a fluidsample, the device comprising: a substantially disk-shaped body having aperiphery; a capillary channel extending through the body and bounded bythe periphery, having a first end and a second end, wherein the firstend is adapted to draw the fluid into the channel by capillary action;and an axis of rotation extending through the center of the disk andwhich is substantially perpendicular to the major surface of thedisk-shaped body; and a cartridge having a housing comprising an airvent in fluid communication with the capillary channel when the disk isrotated in a first position, and containing a sample manipulationdevice, wherein the sample collection device is rotatably positionedwithin the cartridge housing and at least a portion of the side and topsurface of the disk are exposed for application of sample.

11. A working element as disclosed in embodiment 10, wherein the airvent is located in the vicinity of and in fluid communication with thesecond end of the capillary channel when the disk is rotated in a firstposition.

12. A working element as disclosed in embodiment 10, wherein the samplemanipulation device includes a pre-manipulation portion.

13. A working element as disclosed in embodiment 10, wherein the samplemanipulation device is an analytical chamber having an analyticalreagent thereon.

14. A working element as disclosed in embodiment 13, wherein theanalytical chamber is a lateral flow assay device.

15. A working element as disclosed in embodiment 10, wherein the samplecollection device is located at a first end of the cartridge housing andthe portion of the side and top surface exposed are exposed at the firstend of the cartridge.

16. A working element as disclosed in embodiment 15, wherein samplecollection device protrudes from the first end of the cartridge housing.

17. A working element as disclosed in embodiment 15, wherein the samplecollection device is fully contained within the cartridge housing and aportion of the cartridge housing is recessed from the first end to forma notch exposing the side and top surface of the disk.

18. A working element as disclosed in embodiment 15, wherein when thesample collection device is rotated at a second position, the first endof the capillary channel is exposed at the first end of the cartridge.

19. A working element as disclosed in embodiment 15, wherein when thesample collection device is rotated at a third position, the second endof the capillary channel is exposed at the first end of the cartridge.

20. A working element as disclosed in embodiment 10, wherein when thedisk is rotated in the first position, the first end is in communicationwith the sample manipulation device.

21. A working element as disclosed in embodiment 20, wherein the airvent is adapted to be connected to a source of air pressure to forcesample from the capillary channel through the first end and into thesample manipulation device.

22. A method for collecting a sample comprising: providing a workingelement comprising: a sample collection device for a fluid sample, thedevice comprising: a substantially disk-shaped body having a periphery;a capillary channel extending through the body and bounded by theperiphery, having a first end and a second end, wherein the first end isadapted to draw the fluid into the channel by capillary action; a samplecollection well located in the vicinity of the second end and in fluidcommunication with the capillary channel; and an axis of rotationextending through the center of the disk and which is substantiallyperpendicular to the major surface of the disk-shaped body; and acartridge having a housing comprising an air vent in fluid communicationwith the capillary channel when the disk is rotated in a first position,and containing a sample manipulation device, wherein the samplecollection device is rotatably positioned within the cartridge and atleast a portion of the side and top surface of the disk are exposed forapplication of sample;

rotating the sample collection device to a second position to positionthe first end into contact with a sample, or rotating the samplecollection device into a third position to position the samplecollection well into contact with a sample; collecting the sample intothe sample collection device; rotating the sample collection device tothe first position to position the first end into position with thesample manipulation device; and applying air pressure to the air vent toforce the sample across the barrier and into contact with the samplemanipulation device.

23. A method as disclosed in embodiment 22, wherein the air vent islocated in the vicinity of and in fluid communication with the secondend of the capillary channel when the disk is rotated in a firstposition.

24. A method as disclosed in embodiment 22, wherein the samplemanipulation device includes a pre-manipulation portion.

25. A method as disclosed in embodiment 22, wherein the step of rotatingthe sample collection device to position the first or second end intocontact with a sample further comprises rotating the sample collectiondevice to the second position such that the first end extends away fromthe cartridge; and bringing the first end into contact with the sample,whereby capillary action draws the sample into the channel and to thebarrier.

26. A method as disclosed in embodiment 25, wherein the step of bringingthe first end into contact with the sample comprises bringing the firstend into contact with a drop of blood on an animal.

27. A method as disclosed in embodiment 25, wherein the rotation fromthe second position to the first position is approximately 180 degrees.

28. A method as disclosed in embodiment 22, wherein the step of rotatingthe sample collection device to position the first or second end intocontact with a sample further comprises rotating the sample collectiondevice to the third position.

29. A method as disclosed in embodiment 28, wherein the step of bringingthe second end into contact with the sample comprises bringing thesecond end into contact with a syringe containing blood from an animal.

30. A method as disclosed in embodiment 29, wherein the rotation fromthe third position to the first position is approximately 90 degrees.

31. A method as disclosed in embodiment 22, wherein the sample is anaqueous fluid sample.

32. A method as disclosed in embodiment 31, wherein the sample is wholeblood, serum, plasma or urine.

33. A method as disclosed in embodiment 29, wherein the animal is amammal.

34. A method as disclosed in embodiment 26 wherein the animal is amammal.

35. A method as disclosed in embodiment 33, wherein the mammal is ahuman.

36. A method as disclosed in embodiment 34, wherein the mammal is ahuman.

37. A method of performing an assay on a liquid sample for the presenceor concentration of one or more analyte(s) or control(s), on the assaydevice according to embodiment 22, comprising: rotating the samplecollection device to a second position to position the first end intocontact with the sample, or rotating the sample collection device into athird position to position the sample collection well into contact withthe sample; collecting the sample into the sample collection device;rotating the sample collection device to the first position to positionthe first end into position with the assay device; and applying airpressure to the air vent to force the sample into contact with a sampleaddition zone of the assay device; moving the sample by capillary actionthrough a fluid flow path into a reagent zone where it dissolves one ormore reagents; flowing the sample away from the reagent zone having adissolved reagent plume containing one or more reagents and intodetection zone(s) by capillary action through the fluid flow path,wherein signal(s) representative of the presence or concentration ofanalyte(s) or control(s) is produced; and reading the signal(s) that areproduced in the detection zones to determine the presence orconcentration of the analytes or controls.

Those skilled in the art will appreciate that the invention andembodiments thereof described herein are susceptible to variations andmodifications other than those specifically described. It is to beunderstood that the invention includes all such variations andmodifications. The invention also includes all of the steps and featuresreferred to in this specification, individually or collectively, and anyand all combinations of any two or more of the steps or features.

What is claimed is:
 1. A sample collection device for a fluid sample,the device comprising: a substantially disk-shaped body having aperiphery; a capillary channel extending through the body and bounded bythe periphery, having a first end and a second end, wherein the firstend is adapted to draw the fluid into the channel by capillary action; asample collection well located in the vicinity of the second end and influid communication with the capillary channel; and an axis of rotationextending through the center of the disk-shaped body and which issubstantially perpendicular to a major surface of the disk-shaped body.2. The sample collection device as claimed in claim 1, wherein thesample collection device is adapted to rotate about the axis of rotationwithin a cartridge having a housing comprising an air vent in fluidcommunication with the capillary channel when the disk-shaped body isrotated in a first position.
 3. The sample collection device as claimedin claim 2, wherein the air vent is located in the vicinity of and influid communication with the second end of the capillary channel whenthe disk-shaped body is rotated in a first position.
 4. The samplecollection device as claimed in claim 1, wherein the opening of thefirst end is located on a side surface of the disk-shaped body and thesample collection well is located on a top surface of the disk-shapedbody.
 5. The sample collection device as claimed in claim 1, wherein thecapillary channel is non-linear.
 6. The sample collection device asclaimed in claim 5, wherein the capillary channel has a semi-circularshape.
 7. The sample collection device as claimed in claim 6, whereinthe capillary channel has a staff shape.
 8. The sample collection deviceas claimed in claim 1, wherein the first end is hydrophilic of thecapillary channel is hydrophilic.
 9. The sample collection device asclaimed in claim 8, wherein the first end of the capillary channel isprovided with a hydrophilic coating.
 10. A working element comprising: asample collection device according to claim 1; and a cartridge having ahousing comprising an air vent in fluid communication with the capillarychannel when the disk-shaped body is rotated in a first position, andcontaining a sample manipulation device, wherein the sample collectiondevice is rotatably positioned within the cartridge housing and at leasta portion of a side and a top surface of the disk-shaped body areexposed for application of sample.
 11. The working element as claimed inclaim 10, wherein the air vent is located in the vicinity of and influid communication with the second end of the capillary channel whenthe disk-shaped body is rotated in a first position.
 12. The workingelement as claimed in claim 10, wherein the sample manipulation deviceincludes a pre-manipulation portion.
 13. The working element as claimedin claim 10, wherein the sample manipulation device is an analyticalchamber having an analytical reagent thereon.
 14. The working element asclaimed in claim 13, wherein the analytical chamber is a lateral flowassay device.
 15. The working element as claimed in claim 10, whereinthe sample collection device is located at a first end of the cartridgehousing and the portion of the side and top surface are exposed at afirst end of the cartridge housing.
 16. The working element as claimedin claim 15, wherein the sample collection device protrudes from thefirst end of the cartridge housing.
 17. A working element as claimed inclaim 15, wherein the sample collection device is fully contained withinthe cartridge housing and a portion of the cartridge housing is recessedfrom the first end to form a notch exposing the side and top surface ofthe disk-shaped body.
 18. A working element as claimed in claim 15,wherein when the sample collection device is rotated at a secondposition, the first end of the capillary channel is exposed at the firstend of the cartridge housing.
 19. A working element as claimed in claim15, wherein when the sample collection device is rotated at a thirdposition, the second end of the capillary channel is exposed at thefirst end of the cartridge housing.
 20. A working element as claimed inclaim 10, wherein when the disk-shaped body is rotated in the firstposition, the first end of the capillary channel is in communicationwith the sample manipulation device.
 21. A working element as claimed inclaim 20, wherein the air vent is adapted to be connected to a source ofair pressure to force sample from the capillary channel through thefirst end of the capillary channel and into the sample manipulationdevice.